Course Description

The Webinar will discuss the importance of preparing for and participating in a computer system validation audit by regulatory agencies. Regulatory agencies fully expect companies to comply with the computer system validation guidelines that were established in 1983 and have evolved over the last thirty years to align with changes in technology and best practices developed by industry, including the inclusion of risk assessment as a critical component of validation.

Validation of computer systems in the regulatory environment must be a continuous rather than a discrete process. When auditing, regulatory agencies will expect you to have adequately planned and executed your computer system validation effort, and continue to maintain your system in a validated state.

There are specific best practices to be followed that will ensure you are fully prepared to defend your program and prove that you have thoroughly validated your computer systems that are subject to regulatory scrutiny. Being prepared will ensure a much easier interaction with the regulatory agency and will minimize the time and cost of the audit. A company’s readiness may also minimize the risk of findings and citations by showing the auditors that you have done due diligence and are able to respond adequately to all questions and requests for information in a timely manner.

Webinar Takeaway

  • Describe the key components and importance of regulatory audits of validated computer systems
  • Discuss best practices for preparing for a computer system validation audit by a regulatory agency
  • Provide examples of the documentation you can prepare to minimize risk and ensure your audit is successful
  • Discuss best practices for participating in a computer system validation audit by a regulatory agency
  • Provide examples of what you can do during the audit to minimize risk, time and overall cost
  • Discuss best practices for developing a positive relationship with regulatory agency auditors and building a reputation for preparedness, thoroughness and integrity
  • Interactive Q&A Session

Who Will Benefit

This webinar is intended for those working in FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

  • Compliance and Audit Managers
  • Information Technology Analysts
  • Information Technology Developers and Testers
  • QC/QA Managers and Analysts
  • Clinical Data Managers and Scientists
  • Analytical Chemists
  • Laboratory Managers
  • Automation Analysts
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders/Subject Matter Experts
  • Business System/Application Testers

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Faculty Carolyn Troiano

Faculty Carolyn Troiano

  • Midlothian, Virginia, United States

Award winning FDA Compliance Speaker for Validation, 21 CFR Part 11 (Electronic Records/Signatures) and Data Integrity.

My experience includes 34+ years in IT/ Business, Marketing & Compliance leadership and management roles at a variety of Fortune 100 companies, across multiple industries.

My successes include building and managing teams and business units at multiple “greenfield” sites in the pharmaceutical, biotechnology and IT consulting industries, as well as in the public sector. I have weathered numerous layoffs, mergers and acquisitions, and demonstrated my very strong leadership skills in helping staff get through difficult times.